UNITED THERAPEUTICS Corp Q4 FY2023 Earnings Call

Good morning, and welcome to the United Therapeutics Corporation Fourth Quarter 2023 Earnings Webcast. My name is David, and I will be your conference operator today. All participants on the call will be in a listen-only mode until the question-and-answer portion of the earnings call. Please note, this event is being recorded. I would now like to turn the conference over to Dewey Steadman, Head of Investor Relations at United Therapeutics.

Thank you, David, and good morning. It's my pleasure to welcome you to the United Therapeutics Corporation's Fourth Quarter 2023 Earnings Webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update those forward-looking statements. Today's remarks also may discuss the progress and results of clinical trials or other developments with respect to our products and these remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer; Michael Benkowitz, our President and Chief Operating Officer; James Edgemond, our Chief Financial Officer and Treasurer; Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation; and Pat Poisson, our Executive Vice President of Technical Operations. Note that James and I will be participating in one-on-one meetings at the 2023 UBS European Healthcare conference on February 27th in London. Michael, James, and I will participate in a fireside chat and one-on-one meetings at the TD Cowen Healthcare conference on March 5 in Boston, and Pat Poisson and I will participate in a fireside chat and one-on-one meetings at the Leerink Partners Global Biopharma Conference on March 12 in Miami. Our scientific, commercial, and medical affairs teams will present at the American College of Cardiology 73rd Scientific Sessions, April 6 through 8 in Atlanta; the International Society for Heart and Lung Transplantation, April 10 through 13 in Prague; and the American Thoracic Society International Conference on May 17 through 22 in San Diego. And now, I will turn the webcast over to Dr. Rothblatt for an overview of our fourth quarter 2023 financial results and the business activities of United Therapeutics. Martine?

Thank you, Dewey. Good morning, everyone, and a good day to those who are on the other side of the oceans. Congratulations to the 1,200 Unitherians who worked tirelessly every day to help us achieve our third straight quarter of record revenue and our second straight year of record revenue. We again achieved over 20% quarterly and annual revenue growth for the fourth quarter and the full year 2023. Earlier this year, we received important external validation of the value of our Tyvaso DPI business through a royalty transaction executed by our partners at MannKind Corporation. To put it simply, MannKind sold a tenth of their 10% royalty payment stream from us, which equates to 1% of Tyvaso DPI sales for $150 million, plus other milestones. That implies an external valuation of the entirety of the Tyvaso DPI revenue stream of $15 billion before even factoring in the additional potential milestones. That's well above the current market cap for our entire business. Importantly, this valuation is far above the Wall Street valuation of our entire company and is for only one of our many products. At United Therapeutics, we talk about being positioned for three waves of growth, and let's dive into the many reasons why we're so confident in our business. Our first wave of growth will come through our existing commercial business, led by Tyvaso in PH-ILD. We continue to post solid growth in our current business with our third consecutive quarter of record revenues for Tyvaso and revenue growth for our US Remodulin business, despite the presence of competition in the market for the past five years. Our growth in PH-ILD and continued leadership in pulmonary arterial hypertension (PAH) has led our nebulized Tyvaso and Tyvaso DPI products to become the most prescribed prostacyclin therapy in the United States. Michael will go into detail on this exciting aspect of our commercial business. Our second wave of growth will come from our near-term pipeline led by the TETON studies in pulmonary fibrosis and the ADVANCE OUTCOMES study of ralinepag in PAH. These programs should enable us to continue our double-digit annual growth trend through the second half of the decade. I will provide updates on the TETON and ralinepag programs shortly. Of course, both our first and second waves of growth are subject to clinical trial outcomes, regulatory approvals, new competitive entrants, and the potential impacts of the Inflation Reduction Act, but we feel good about our prospects for meeting these revenue growth targets. Our third wave of sustainable growth will come through the development, manufacture, and widespread use of manufactured organs and organ technologies to provide a solution to patients suffering from end-stage kidney, lung, heart, and liver disease. Moving to our near-term pipeline and second wave of growth. We have four key registration trials underway, three TETON studies for pulmonary fibrosis and the ADVANCE OUTCOMES study for ralinepag, an oral therapy for Group 1 PAH. We also advanced our MiroliverELAP program towards the clinic with a recent and historic IND clearance by the FDA. Moving to TETON, we believe IPF represents a 100,000 patient opportunity in the United States with only two approved therapies that nearly slow lung function decline. Both TETON 1 and TETON 2 are enrolling patients. At this time, we are aiming for full enrollment in both studies with 576 patients each by the end of this calendar year. Likewise, we believe PPF or progressive pulmonary fibrosis represents a 60,000-patient opportunity in the US alone. This disease is quite distinct from IPF or idiopathic pulmonary fibrosis. One of the two FDA approved IPF therapies is also approved for PPF and, as in IPF, it only slows the decline of lung function in these fragile patients. The TETON PPF study dosed its first patients in the fourth quarter of 2023, right on schedule, and we expect this trial to enroll 698 patients. We believe there is a high probability of success in the three TETON studies based on the IPF subset analysis of the INCREASE study of nebulized Tyvaso in PH-ILD patients. Unlike the two IPF studies that are already on the market, nebulized Tyvaso in a safety endpoint showed an actual improvement of lung function in the subset of patients that had IPF along with their pulmonary hypertension. That gives so many people hope. Now let's move on to ralinepag and our ADVANCE OUTCOMES study in Group I PAH, which continues to enroll patients. We expect completion of the study in 2025. We are targeting 700 to 1,000 patients in this study depending on the pace of accruing clinical worsening events. Ralinepag is a next-generation selective and potent prostacyclin receptor agonist we are developing as a once-daily oral therapy for PAH. We believe ralinepag's once-daily dosing, sustained release profile, and titratability position it favorably against the other oral prostacyclin receptor agonists on the market as well as other therapies for PAH patients. Ralinepag provides 24-hour coverage with higher potency than the other oral prostacyclin agonists as demonstrated by in vitro assays, and ralinepag showed over 20% improvement in pulmonary vascular resistance in a Phase 2 study. A long-term Phase 2 open-label study of ralinepag also showed sustained improvement in six-minute walk distance over more than two years. A manuscript recently published in the journal Advances in Therapy describes these exciting findings. While we and others have made progress at extending lives and improving patient outcomes through treprostinil and other therapies, the only known cure for PAH remains a lung transplant. That also is the case for IPF. The problem for PAH, IPF, and many other patients with end-stage organ disease is that there aren't enough donors and transplantable organs available to address the need. For many organ donations, one life must be lost to save another. We believe the best solution is to create an unlimited supply of tolerable transplantable manufactured organs; with an unlimited supply of organs, transplantation can become a consideration for countless end-stage organ diseases for which there are few good treatment options. Accordingly, we have been developing several investigational approaches using multiple technologies with different organs all with this same goal in mind. The first is our ex vivo lung perfusion service or EVLP, which has led to over 380 lives saved with lungs that have undergone EVLP in our facilities in Silver Spring, Maryland, and at the Mayo Clinic Jacksonville campus. Beyond EVLP, we have four platforms—xenotransplantation, regenerative medicine, 3D bioprinting, and bioartificial organs. These four platforms cover four key organs: lung, heart, kidney, and liver. Starting with xenotransplantation, we continue to work with the FDA on the clinical path forward. We're underway with pivotal preclinical studies in baboons at the request of the agency. Specifically, for our 10-gene program, we expect the last preclinical xeno-kidney transplant to occur in the first half of 2024. We expect to meet with the agency later this year to discuss the IND and clinical protocol for human studies for 10-gene xeno organs. In parallel with the pivotal preclinical studies, the construction of our clinical scale Designated Pathogen-Free facility in Virginia is complete, and we dedicated the facility earlier this month. We expect the facility to begin receiving pigs this quarter and to grow its population throughout 2024 in preparation for clinical studies in humans for both xeno-kidneys and xeno-hearts. This is incredibly exciting and brings a lot of hope into the entire transplant space. Last month, we received FDA clearance of our investigational new drug application that allows the MiroliverELAP system to enter human clinical trials. This non-registration study will be the first-ever clinical study of a bioengineered organ. MiroliverELAP is an external liver-assist product designed to provide liver support in the critical care setting. Acute liver failure is a devastating condition with no approved therapies. A liver transplant is often the only way to save these patients. The ELAP is intended to give the patient's liver a chance to heal itself, possibly reducing the need for liver transplantation. We look forward to providing more details on this program in the coming quarters. I'm thrilled that we're in such a great position at United Therapeutics. We have a solid commercial business, posting record results with continued strong growth ahead, a pipeline of novel therapies that continue our strong double-digit revenue growth, and a long-term plan to address one of the largest, critical, unmet medical needs in medicine, all while helping our patients, employees, and shareholders succeed. I'll now turn the call over to our President, Michael Benkowitz, who will give an overview of our commercial performance and expectations for potential competition this year.

Thank you, Martine, and good morning, everyone. As Martine noted, today we reported our highest revenue quarter ever at $615 million, up 25% from the fourth quarter of 2022, and record annual revenues of more than $2.3 billion, up 20% over 2022. Importantly, we saw meaningful growth across our entire suite of products, including the Tyvaso franchise, Remodulin in the US, Orenitram, and Unituxin. Starting with Orenitram, revenue of $84 million during the quarter was up 11% from the prior year. This growth reflects increases in volume, price and average dose. Following the publication of two peer-reviewed manuscripts in 2023, our medical affairs teams began providing education on data from the EXPEDITE study, which assessed the Orenitram dose achieved after a rapid Remodulin titration and then transition to Orenitram. Worldwide Remodulin revenue of $115 million for the fourth quarter was down 6% from last year, primarily impacted by international order timing. However, U.S. Remodulin revenue of $106 million was up 9% from the fourth quarter of 2022. Remodulin, both intravenous and subcutaneous, remains the most prescribed parenteral prostacyclin in the U.S. We expect this momentum to continue in the U.S., as we had a near-record number of referrals and starts during the fourth quarter, driven in part by interest in the EXPEDITE study results. Worldwide Unituxin revenue of $54 million in the fourth quarter was up 48% from the prior year quarter, and U.S. Unituxin revenue of $49 million was up 34%. U.S. growth was driven by price and volume, and these volume gains were driven primarily through a modest inventory build at our distributor. International ordering driven by our partner in Japan was strong over a comparably soft quarter in 2022. Finally, worldwide Tyvaso revenue was up 45% to $351 million, our highest quarter ever. U.S. revenue was up 40% to $337 million, and was the highest quarter ever. U.S. growth in Tyvaso was led by the continued uptake of Tyvaso DPI. Tyvaso nebulizer and Tyvaso DPI remain the number one prescribed prostacyclin treatment in the U.S. and remain the only approved therapies for PH-ILD. We're pleased to report that there were no material changes in inventories of Tyvaso DPI at our Specialty Pharmacy distributors during the fourth quarter, and that both distributors remain within their contracted inventory levels. The expansion of our partner MannKind's production capacity over the summer of 2023 continues to be sufficient to meet current demand, and a further expansion at MannKind is expected to come online in the coming months, which will allow us to reach as many as 25,000 patients per year with Tyvaso DPI. Assuming normal production operations at MannKind, we do not expect any supply constraints moving forward. Interestingly, after the launch of Tyvaso DPI in May of 2022, and the subsequent expected decline in revenue for Nebulizer Tyvaso, we are starting to see modest sequential growth in U.S. Nebulizer Tyvaso revenue, a key reminder of the importance of the Nebulizer for patients with pulmonary hypertension. Some physicians and patients continue to prefer the Nebulizer because of its use profile or for reimbursement reasons. In addition, we are aware that some pulmonologists prefer to start and titrate their PH-ILD patients using the Nebulizer before switching to Tyvaso DPI. This allows for more precise titration in one-breath increments compared to the three-breath equivalent increments of Tyvaso DPI. We expect this platform strategy to emerge as a competitive advantage over other potential DPI products should they reach the market. Now, we've heard a lot about potential competition for Tyvaso DPI, and I'd like to share several reasons why we're confident we will have the preferred dry powder inhaler for patients with PAH and PH-ILD. First, Tyvaso DPI requires only one breath per cartridge compared to two breaths for the potential competitor. Our low flow design requires less patient breath than potential high flow devices that may reach the market. In patients with compromised lungs, we think that the less breath required through a low-flow device will be seen as a fundamental benefit by both patients and prescribers. Next, the low flow design of Tyvaso DPI allows for consistent deep lung delivery. This means we can achieve similar blood levels as the nebulizer with less treprostinil than high flow devices. The Dreamboat device for Tyvaso DPI requires no cleaning or maintenance, saving patients time and effort compared to other potential devices that may reach the market. Additionally, Tyvaso DPI is labeled for room temperature storage by patients, another important convenience point. There's no maximum label dose for Tyvaso or Tyvaso DPI despite claims to the contrary by our potential competitors. Finally, the BREEZE study also demonstrated 98% patient satisfaction with Tyvaso DPI. These factors, coupled with the experience physicians have gained through the rapid uptake of Tyvaso DPI since launch, lead us to believe that Tyvaso DPI will compete as effectively with similar product offerings in the inhaled market as Remodulin has competed with similar offerings in the parenteral market. Moving on to the other potential competitor this year, the PAH community is anticipating the March FDA action date for the first potential activin signaling inhibitor for the treatment of Group 1 PAH. While we understand that there is excitement for this new pathway and we've seen this in the past with new offerings, it's important to remember that PAH is a complex multi-factorial disease where polytherapy is the norm, not the exception, and treating multiple pathways of the disease aggressively and early is critical to patient outcomes. Based on the results of this new product's clinical trial and our conversations with prescribers, it does not appear that an activin signaling inhibitor is either a cure for PAH or a replacement for prostacyclin therapy. In fact, in their pivotal trial, 70% of patients were on prostacyclin therapy with 40% on a parenteral prostacyclin, Remodulin. Therefore, we see this therapy as additive to our existing prostacyclin patients. If the activin signaling inhibitor helps further improve outcomes, then these patients should stay on our therapies longer. For those patients not yet on a prostacyclin therapy, PAH is a progressive disease and the vast majority of these patients will eventually need a prostacyclin. Whether that's before or after initiating activin signaling inhibitor will be case dependent. Given that polytherapy is becoming the norm, we believe Tyvaso DPI offers patients and prescribers a convenient way to cover the prostacyclin pathway earlier in a patient's disease journey. Finally, we want to remind investors that this launch will only be in Group 1 PAH and will not affect our growing PH-ILD business where the activin signaling pathway has not been studied. That brings us to the profile of treprostinil-based prostacyclins like Tyvaso, Remodulin, and Orenitram. We have over two decades of use and safety data to support the use of treprostinil in PAH patients. There's a correlation between prostacyclin dose and patient outcomes. Treprostinil has demonstrated improvement across a wide array of key hemodynamic parameters and no regular blood testing is required for prostacyclin use. To wrap up, while we're entering a year of potentially increasing competition, we remain confident that we have the product portfolio, clinical data, support structures, and expertise to succeed in the emerging competitive landscape. We're extremely proud of our continued record performance this past quarter and the entire year, and we think we're in the early stages of sustainable growth for our current commercial portfolio. With that, I'll turn the call back over to Martine to run the Q&A.

Thanks, Mike. Congratulations again to you and your entire sales, commercialization, marketing, strategic operations, and allied health teams that have achieved sequential records in quarters and years of growth in these products. It's just really beyond awesome. Thank you so much. Operator, you can now open up the lines for any questions.

We will now begin the question-and-answer session. Our first question comes from Roanna Ruiz with Leerink Partners. Please go ahead.

Hey. Good morning, everyone. I was curious if you could talk a bit about the underlying patient demand in the quarter for Tyvaso, both the DPI and the nebulizer, and any other key drivers that you're seeing. Additionally, in terms of the big picture, are you seeing anything interesting in the inventory dynamics going into the first quarter this year?

Thanks, Roanna, for your question. It seems Mike would be the best person on the call to answer those questions. He did touch upon those points in his introductory remarks, but Mike, maybe you can provide a little bit more detail.

Sure. Yes. From a demand standpoint for the Tyvaso franchise, we were really happy with the demand metrics in the fourth quarter. Referrals came in at or above what I can say is a record fourth quarter. New patient starts, which is unusual given we talk a lot about the cyclicality or seasonality, particularly in the fourth quarter with the holidays and fewer shipping days. So, it's really nice to see that we were able to buck that trend on the referral side. Speaking of new patient starts, we’re pulling those through. One phenomenon that I had mentioned in past years with respect to the fourth quarter is that, when referrals come in, sometimes between particularly between Thanksgiving and the end of the year as people are settling into their holiday routines, patients are sometimes reluctant to start therapy. So, they delay the start of the therapy until after the first of the year. We did see a little bit of that on the start side, so record referrals, but the percentage of those that converted to starts within the quarter as compared to prior quarters was slightly down, but we're starting to see those pull through in the first quarter. So again, that's not uncommon and we see that typically every year. From a demand standpoint, we’re really happy with how the commercial teams are performing, the continued uptake of Tyvaso DPI in both PAH and PH-ILD, and then generally the continued growth in the PH-ILD business. From an inventory standpoint, as Martine alluded to and as I said in my opening remarks, I think we feel really good about where we are from an inventory standpoint. MannKind is among the partners, and with the process and increased capacity improvements they made over the summer, they seem to be running smoothly. We're able to ensure that specialty pharmacy is staying within their contractual orders. That has held true for the last couple of quarters now, and with more capacity coming online later this year, as I said earlier, we don't expect any type of supply constraints or anomalies on the inventory side.

Perfect. Michael, thank you so much. Operator, next question.

The next question comes from Ash Verma with UBS. Please go ahead.

Hi. Congrats on the progress. Thanks for taking our questions. So, maybe just starting off with the middle lever. Can you elaborate a little bit on what the clinical study design would look like? And then, in terms of the DPI out-of-pocket cost this year with the IRA catastrophic limit implementation, would that normalize the out-of-pocket costs compared to the nebulizer? Or would we start to see more of that benefit in 2025? Thanks.

Okay. Ash, it sounds to me like you had one question on the clinical trial design for the Xeno program, and then flipped to another topic regarding the IRA aspect. Why don't we start with Dr. Peterson sharing her thoughts on the clinical development way forward for Xeno? Then, Mike can share some more thoughts about reimbursement issues. Dr. Peterson?

Yes, sure. For the Xeno program, regarding our 10-gene xenokidney and 10-gene xenoheart, we are continuing to conduct our IND-enabling studies with our partners at the University of Maryland and Johns Hopkins. We expect these studies to finish, and we will start meeting with the FDA to discuss the specific clinical protocols for those programs with the intent of starting the 10-gene xenokidney study in 2025, as well as possibly the 10-gene xenoheart.

Thanks, Dr. Peterson. Ash, I think I might have misheard a bit regarding your trial question, which was related to the ELAP study. For that, I would refer you to what is posted at clinicaltrials.gov. This is the first time the FDA has approved a bioengineered organ for clinical trials, which is a huge achievement, and great credit goes to Jeff Ross and his team at Miromatrix for getting us to this point. The details from that study include a Phase 1 safety study that you can read about on the FDA's website. We're really excited about many pathways and platforms in our organ transplantation business, and we're excited to have the MiroliverELAP serve as a pathfinder as we bring more manufactured organs into the clinic. Mike, do you want to comment on the IRA?

Sure, happy to. So, Ash, your question was about the changes to the IRA and how they could potentially impact out-of-pocket costs for patients using DPI versus the nebulizer. There are still some differences between DPI and nebulizer, particularly related to Part D and Part B coverage and out-of-pocket expenses depending on whether a patient has supplemental insurance in Part B, etc. But we feel comfortable saying that to the extent that reimbursement was a barrier to starting DPI, that will largely go away with the changes to patient out-of-pocket expenses in Part D. We are actually starting to see some benefits of that. To provide a quick background, the 5% out-of-pocket in the catastrophic phase goes away starting this year for patients. The out-of-pocket for a patient right now is estimated to be around $3,000 to $3,500, which covers all drugs, not per drug. This means they must spend that before Medicare kicks in in 2024. As for 2025, patients will be able to spread that spending over 12 months, and the $3,500 out-of-pocket ceiling drops to $2,000. So with these factors—the lower out-of-pocket costs and the ability to spread expenses over 12 months—we expect utilization of our patient assistance program to reduce. In fact, we’ve already observed a surprising number of patients transitioning from patient assistance to commercial drug status in the first quarter. I anticipate that once we move past the first quarter, most of our patients in patient assistance, with their multiple therapies, will have spent their out-of-pocket limit before moving into the second quarter. We expect that as the year progresses, fewer patients will need to use our patient assistance program, so our PAP utilization will continue to decline over the year and into 2025.

That's fantastic, Mike. We've been well prepared for the IRA impacts well ahead of time, and all that groundwork and preparation is certainly paying off. Is there a next question from the operator?

Yes, the next question comes from Jessica Fye with JPMorgan. Please go ahead.

Hey, guys. Good morning. Thanks so much for taking my question. You mentioned sotatercept not coming to market in PH-ILD. I know it's sort of tough to tell, but just given the investor questions we get about the pending competition in PAH, can you give us your latest thinking on the mix of Tyvaso patients being treated for PAH versus PH-ILD and how that mix might evolve going forward as PH-ILD usage continues to ramp? If that mix is not answerable, can you elaborate on which of your treprostinil products you see as least likely to see disruption from sotatercept? And why? Thank you.

Thanks, Jess. Good to hear your voice this morning. Mike will take your question.

Sure. Yes. In terms of the mix of PAH and PH-ILD with Tyvaso, we said at your conference earlier this quarter that we believe it’s around 50-50. It's not a perfectly knowable answer due to the way information comes in through referral forms, but we feel confident it's in that 50-50 mix, and it should continue to increase in favor of PH-ILD as we get out and communicate with prescribers more effectively. We've discussed the expansion of our sales force in the second half of last year, which is now complete. Those sales representatives are training and are now hitting the field. As we progress into the remainder of 2024, we expect to see benefits from a larger share of voice in PH-ILD as clinicians become more diligent and comfortable referring patients to PAH clinics or treating those patients themselves with Tyvaso nebulizer or DPI. Over time, we see PH-ILD as a significant growth opportunity, and that mix will trend in favor of PH-ILD as we move forward. Regarding your query on which drug in PAH is least likely to be impacted, I have conviction that there won't be much impact because all patients will eventually require a prostacyclin. It boils down to the sequencing, which will depend on the patient. Currently, I would suggest that Remodulin is probably the least likely to be impacted since patients on Remodulin tend to be more advanced or severe cases. If a patient presents with severe pulmonary hypertension, most physicians will likely reach for Remodulin first. There's no evidence suggesting patients will be switched off a prostacyclin first in favor of sotatercept.

Thank you, Mike. Those were great insights. Operator, are there more questions?

Yes. One more question from Andreas Argyrides with Wedbush Securities. Please go ahead.

Good morning and thanks for squeezing in our questions. Again, congrats on the progress this quarter. Just two from us here. On the competitor front, how do you see safety playing a key role in adoption for new therapies? Also, as we approach TETON readouts, how do you think about the opportunity for Tyvaso in IPF and its place in the treatment landscape? Lastly, considering you have quite a bit of cash and were busy on the business development front last quarter, how do you view business development opportunities and areas you might pursue going forward? Thanks so much.

Alright. Let's take that one step at a time. Capital allocation discussions at United Therapeutics are under the management of our Chief Financial Officer, James Edgemond. So I'll have him speak first. Regarding competitive product positioning, Mike will share some insights. Lastly, Dr. Peterson will address safety monitoring aspects in clinical trials and share some thoughts about our stellar pharmacovigilance and drug safety group. Safety is always our only priority at United Therapeutics. James, can you dive into capital allocation?

Thank you, Martine. Andreas, it's great to hear from you this morning. In response to your two questions, I’ll start with capital allocation. Our priorities remain unchanged: internal research and development, business and corporate development, and then returning capital to shareholders. We see ample opportunities to invest in ourselves and in complementary businesses at this time. At the JPMorgan conference in January, Martine laid out the need to quickly access and deploy capital to support the potential commercial scale build-out of DPS facilities, which could require several billion dollars in CapEx over the next several years. We've had substantial discussions regarding capital allocation, specifically focused on manufactured organs. Transitioning to business and corporate development, we are constantly seeking potential acquisitions and in-licensing opportunities. We're particularly interested in complementary products and platforms targeting rare lung diseases and other cardiovascular conditions. Recently, we disclosed two acquisitions—IVIVA and Miromatrix—that focus on organ manufacturing.

Thank you, James. Now Mike, could you elaborate on how safety plays a role in the adoption of new therapies?

Sure. Andreas, your first question was about how safety factors into new therapies and their adoption. I believe it's largely up to prescribers and those manufacturers. Each product has a safety profile that gets presented alongside clinical efficacy, and physicians need to evaluate the benefits compared to risks pertaining to that product relative to a patient's needs and existing available treatments. Ultimately, it will determine patient care and choice over time.

Great. Leigh, I think you're off the hook because Mike has addressed the safety question thoroughly. Operator, are there any more questions?

Thank you for participating in today's United Therapeutics Corporation Earnings Webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website.